Guest guest Posted December 16, 2001 Report Share Posted December 16, 2001 Sheri, what is erythema??? It's listed as one of the (many) side effects. At 10:48 AM 12/16/01 +0000, you wrote: > >Here is the package insert for DTaP. They can all be gotten on ><http://www.pdr.net>www.pdr.net > >SIDS! > >-Dawn > > PDR® entry for >Tripedia (Pasteur Merieux Connaught) > > > >CAUTION: Federal (USA) law prohibits dispensing without prescription. > > > >DESCRIPTION > > >Tripedia®, Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine >Adsorbed (DTaP), for intramuscular use, is a sterile preparation of >diphtheria and tetanus toxoids adsorbed, with acellular pertussis vaccine >in an isotonic sodium chloride solution containing thimerosal as a >preservative and sodium phosphate to control pH. After shaking, the vaccine >is a homogeneous white suspension. Tripedia® vaccine is distributed by >Connaught Laboratories, Inc. (CLI). > >The acellular pertussis vaccine components are isolated from culture fluids >of Phase 1 Bordetella pertussis grown in a modified Stainer-Scholte medium. >1 After purification by salt precipitation, ultracentrifugation, and >ultrafiltration, preparations containing varying amounts of both pertussis >toxin (PT) and filamentous hemagglutinin (FHA) are combined to obtain a 1:1 >ratio and treated with formaldehyde to inactivate PT. Thimerosal (mercury >derivative) 1:10,000 is added as a preservative. > >Corynebacterium diphtheriae cultures are grown in a modified Mueller and > medium. 2 Clostridium tetani cultures are grown in a peptone-based >medium. Both toxins are detoxified with formaldehyde. The detoxified >materials are then separately purified by serial ammonium sulfate >fractionation and diafiltration. > >The toxoids are adsorbed using aluminum potassium sulfate (alum). The >adsorbed diphtheria and tetanus toxoids are combined with acellular >pertussis concentrate, and diluted to a final volume using sterile >phosphate-buffered physiological saline. Thimerosal (mercury derivative) >1:10,000 is added as a preservative. Each 0.5 mL dose contains, by assay, >not more than 0.170 mg of aluminum and not more than 100 µg (0.02%) of >residual formaldehyde. The vaccine contains gelatin and polysorbate 80 >(Tween-80) which are used in the production of the pertussis concentrate. > >Each 0.5 mL dose is formulated to contain 6.7 Lf of diphtheria toxoid and 5 >Lf of tetanus toxoid (both toxoids induce at least 2 units of antitoxin per >mL in the guinea pig potency test), and 46.8 µg of pertussis antigens. This >is represented in the final vaccine as approximately 23.4 µg of inactivated >PT (also referred to as lymphocytosis promoting factor or LPF) and 23.4 µg >of FHA. The inactivated acellular pertussis component contributes not more >than 50 endotoxin units (EU) to the endotoxin content of 1 mL of DTaP. The >potency of the pertussis components is evaluated by measuring the antibody >response to PT and FHA in immunized mice using an ELISA system. > >Acellular Pertussis Vaccine Concentrates (For Further Manufacturing Use) >are produced by The Research Foundation for Microbial Diseases of Osaka >University (BIKEN), Osaka, Japan under United States (US) license, and are >combined with diphtheria and tetanus toxoids manufactured by CLI. The >Tripedia® vaccine is filled, labeled, packaged, and released by CLI. > >TriHIBit®, when Tripedia® vaccine is used to reconstitute ActHIB® for the >fourth dose only , each single dose of combined vaccine (0.5 mL) is >formulated to contain 6.7 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid >(both toxoids induce at least 2 units of antitoxin per mL in the guinea pig >potency test), 46.8 µg of pertussis antigens (approximately 23.4 µg of >inactivated PT and 23.4 µg of FHA), 10 µg of purified Haemophilus >influenzae type b capsular polysaccharide conjugated to 24 µg of >inactivated tetanus toxoid, and 8.5% sucrose. > >(<JavaScript:GotoTop();>back to top) > > > >CLINICAL PHARMACOLOGY > > >Simultaneous immunization against diphtheria, tetanus, and pertussis, using >a conventional " whole-cell " pertussis DTP vaccine (Diphtheria and Tetanus >Toxoids and Pertussis Vaccine Adsorbed - For Pediatric Use), has been a >routine practice during infancy and childhood in the US since the late >1940s. This practice has played a major role in markedly reducing the >incidence rates of cases and deaths from each of these diseases. 3 > >Tripedia® vaccine combines CLI's diphtheria and tetanus toxoids with >purified pertussis antigens (inactivated PT and FHA). These pertussis >antigens have been used routinely for childhood vaccination in Japan since >1981 4,5,6,7 and have been used for investigational purposes in Sweden, >1,8,9,10,11 as well as in the US and Germany. 1,12,13,14,15 In the US, >since 1992, Tripedia® vaccine has been indicated for immunization of >children 15 months to 7 years of age (prior to the seventh birthday) who >have previously been immunized with three or four doses of whole-cell >pertussis DTP. > > > > > >DIPHTHERIA > >Corynebacterium diphtheriae may cause both localized and generalized >disease. The systemic intoxication is caused by diphtheria exotoxin, an >extracellular protein metabolite of toxigenic strains of C. diphtheriae . >Protection against disease is due to the development of neutralizing >antibody to diphtheria toxin. > >Both toxigenic and nontoxigenic strains of C. diphtheriae can cause >disease, but only strains that produce diphtheria toxin cause severe >manifestations, such as myocarditis and neuritis. Diphtheria remains a >serious disease, with the highest case-fatality rates among infants and the >elderly. 3 > >At one time, diphtheria was common in the US. More than 200,000 cases, >primarily among children, were reported in 1921. Approximately 5% to 10% of >cases were fatal; the highest case-fatality rates were in the very young >and the elderly. Reported cases of diphtheria of all types declined from >306 in 1975 to 59 in 1979; most were cutaneous diphtheria reported from a >single state. After 1979, cutaneous diphtheria was no longer reportable. 3 >>From 1980 to 1989, only 24 cases of respiratory diphtheria were reported in >the US; 2 cases were fatal and 18 (75%) occurred among persons >/=20 years >of age. 3 From 1990 through 1994, 15 cases were reported. 16 > >Diphtheria is currently a rare disease in the US primarily because of the >high level of appropriate vaccination among children (97% of children >entering school have reached >/= three doses of diphtheria and tetanus >toxoids and pertussis vaccine adsorbed [DTP]) and because of an apparent >reduction in the circulation of toxigenic strains of C. diphtheriae . 3 >Most cases occur among unvaccinated or inadequately vaccinated persons. 3 >Diphtheria remains a serious disease in some areas of the world as >evidenced by the recent outbreak in the former Soviet Union. 17 > >Complete immunization significantly reduces the risk of developing >diphtheria, and immunized persons who develop disease have milder illness. >Protection is thought to last at least 10 years. Immunization does not, >however, eliminate carriage of C. diphtheriae in the pharynx, nose or on >the skin. 3 > >Efficacy of CLI's diphtheria toxoid used in Tripedia® vaccine was >determined on the basis of immunogenicity studies, with a comparison to a >serological correlate of protection (0.01 antitoxin units/mL) established >by the Panel on Review of Bacterial Vaccines & Toxoids. 18 > > > > > >TETANUS > >Tetanus is an intoxication manifested primarily by neuromuscular >dysfunction caused by a potent exotoxin elaborated by Clostridium tetani . > >The occurrence of tetanus in the US has decreased dramatically from 560 >reported cases in 1947 to an average of 57 cases reported annually from >1985-1994. 16 Tetanus in the US is primarily a disease of older adults. Of >99 tetanus patients with complete information reported to the Centers for >Disease Control and Prevention (CDC) during 1987 and 1988, 68% were >/= 50 >years of age, while only six were < 20 years of age. Overall, the >case-fatality rate was 21%. The disease continues to occur almost >exclusively among persons who are unvaccinated or inadequately vaccinated >or whose vaccination histories are unknown or uncertain. 3 > >In 4% of tetanus cases reported during 1987 and 1988, no wound or other >condition was implicated. Non-acute skin lesions, such as ulcers, or >medical conditions, such as abscesses, were reported in 14% of cases. 3 > >Spores of C. tetani are ubiquitous. Serological tests indicate that >naturally acquired immunity to tetanus toxin does not occur in the US. >Thus, universal primary immunization, with subsequent maintenance of >adequate antitoxin levels by means of appropriately timed boosters, is >necessary to protect all age groups. Tetanus toxoid is a highly effective >antigen, and a completed primary series generally induces protective levels >of serum antitoxin that persist for 10 or more years. 3 > >Efficacy of CLI's tetanus toxoid used in Tripedia® vaccine was determined >on the basis of immunogenicity studies, with a comparison to a serological >correlate of protection (0.01 antitoxin units/mL) established by the Panel >on Review of Bacterial Vaccines & Toxoids. 18 > > > > > >PERTUSSIS > >Since pertussis became a nationally reportable disease in 1922, the highest >number of pertussis cases (approximately 266,000) was reported in 1934. >Following the licensure of whole-cell pertussis DTP vaccine in 1949 and the >widespread use of DTP among infants and children, the incidence of reported >pertussis declined to a historical low of 1,010 cases in 1976. However, >since the early 1980s, reported pertussis incidence has increased with >cyclical peaks occurring in 1983, 1986, 1990, and 1993. Following the peak >in reported cases in 1993, the number declined during 1994 and the first 2 >quarters of 1995, a pattern consistent with the previously observed 3-4 >year periodicity in pertussis incidence. National pertussis surveillance >data for January 1992-December 1994 during which an average of 5,095 cases >were reported annually, demonstrate the continued effectiveness of the >current pertussis vaccination program. 19 > >Pertussis (whooping cough) is a disease of the respiratory tract caused by >Bordetella pertussis . This gram-negative coccobacillus produces a variety >of biologically active components. The role of the different components >produced by B pertussis in either the pathogenesis of, or the immunity to, >pertussis is not well understood. However, efficacy has been demonstrated >for this vaccine that contained both inactivated PT and FHA. > >Pertussis is highly communicable (attack rates of > 90% have been reported >among unvaccinated household contacts 20 ) and can cause severe disease, >particularly among very young children. Of 10,749 patients < 1 year of age >reported nationally as having pertussis during the period 1980 to 1989, 69% >were hospitalized, 22% had pneumonia, 3.0% had one or more seizures, 0.9% >had encephalopathy, and 0.6% died. 21 > >In older children and adults, including some who were previously immunized, >infection may result in nonspecific symptoms of bronchitis or an upper >respiratory tract infection, and pertussis may not be diagnosed because >classic signs, especially the inspiratory whoop, may be absent. Older >preschool-aged children and school-aged siblings who are not fully >immunized and develop pertussis may be important sources of infection for >young infants, the group at highest risk of clinical disease and severe >pertussis. 3 The infected adult may play a role in the transmission of >pertussis. 22,23 > >General use of whole-cell pertussis DTP vaccines has resulted in a >substantial reduction in cases and deaths from pertussis disease. 20,24 The >use of Tripedia® vaccine as a primary series evokes an antibody response >with respect to PT and FHA and has been shown to be effective in clinical >studies. 1 > >Acellular pertussis vaccines have been used in Japan since 1981, mostly in >2-year-old children. Evidence for the efficacy of these vaccines, as a >group, is demonstrated by the decline in pertussis disease with their >routine use in that country. 4,20 In addition, a review of epidemiological >studies of the Japanese acellular pertussis vaccines estimated that these >vaccines, as a group, were 88% efficacious in protecting against clinical >pertussis on household exposure, with a 95% confidence interval (CI) of 79% >to 93%. 25 > >Two clinical studies were conducted to assess the protective efficacy of >these acellular pertussis components of Tripedia® vaccine. A randomized, >controlled clinical trial in Sweden assessed efficacy after only two doses >of the pertussis component in children 5 to 11 months of age. 10 A second >study was conducted in Germany using a three-dose schedule to evaluate the >protective efficacy of the Tripedia® vaccine in younger infants. > >In 1986-1987, a double-blind, randomized, placebo-controlled efficacy trial >of two BIKEN acellular pertussis vaccines was conducted in Sweden. One of >the vaccines was a two-component vaccine comparable to the acellular >pertussis components contained in Tripedia® vaccine. This prospective trial >used a standardized case definition and active case ascertainment. In this >trial, 1,389 children, 5 to 11 months of age (median 8.5 months), received >two doses of the acellular pertussis vaccine 7 to 13 weeks apart and 954 >received a placebo control. During the 15 months of follow-up from 30 days >after the second dose, culture-confirmed whooping cough (cough of any >duration and a positive culture of B pertussis ) occurred in 40 placebo and >18 acellular pertussis vaccine recipients. The point estimate of protective >efficacy for two doses of vaccine was 69% (95% CI; 47% to 82%) for all >cases of culture-confirmed pertussis with any cough 1 day or longer and 79% >(95% CI; 57% to 90%) using a secondary case definition of culture-confirmed >cases with cough of over 30 days duration. 10 In a reanalysis of the >Swedish data efficacy estimates increased with duration of coughing spasms >and when the case definition included whoops and whoops plus at least nine >coughing spasms a day. 26 Using a case definition of cough of 21 days or >more of coughing spasms, confirmed by positive culture resulted in an >efficacy estimate of 81% (95% CI; 61% to 90%). 26 > >Using a passive reporting system, three-year unblinded follow-up of vaccine >and placebo recipients from the above Swedish study has shown a post-trial >efficacy of 77% (95% CI; 65% to 85%) for all culture-proven cases of >pertussis, and an efficacy of 92% (95% CI; 84% to 96%) for culture-proven >cases with a cough of over 30 days duration. 27 > >A case-control study to evaluate the efficacy of Tripedia® vaccine was >conducted in Germany. The study population consisted of patients in 63 >pediatric practices who had no contraindications to pertussis immunization >and were enrolled in the study between the ages of 6 and 17 weeks (actual >range of age at first visit was up to 20 weeks for the DT group). By >parental choice, infants received Tripedia® vaccine or whole-cell pertussis >DTP (Behringwerke, Germany) at approximately 3, 5, and 7 months of age, or >DT, or no vaccine. Cases of pertussis were identified by obtaining cultures >for B pertussis from all patients between the ages of 2 and 24 months who >presented to the physician's office with 7 or more days of cough. >Identification of presumptive cases of pertussis was made by primary care >physicians who were not blinded to the vaccine status of subjects. Cases >were confirmed by positive culture in the subject or positive culture in a >subject's household contact. Duration of cough in study subjects was >determined at an office visit, by telephone, or by home visit 21-24 days >after the onset of cough. > >Four aged-matched controls were selected for each case from the same >pediatric practice. Selection of controls was done without knowledge of >vaccination status. The vaccine (or no vaccine) and number of doses which >each case and control subjects received subsequently was determined from >medical records. > >In order to adjust for potentially confounding variables, information on >sex, race, day-care attendance, well-baby visits, sick-child visits, >pertussis vaccination status of siblings, age of siblings, number of >siblings, day-care attendance of siblings, and parental employment status >was obtained through interview of parents. Information on erythromycin use >was not obtained for the study population. > >A total of 16,780 infants were enrolled in the study, of whom 74.6% >received Tripedia® vaccine and 10.9%, 12.5%, and 2.1% received DTP, DT, or >no vaccine, respectively, by non-random parental choice. A total of 11,017 >cultures for B pertussis was obtained and 140 cases were identified using a >primary case definition of cough >/= 21 days, plus positive culture for B >pertussis or household contact with a person with culture-positive >pertussis. Of the 140 cases, 130 cases were diagnosed on the basis of a >positive culture and 10 on the basis of household contact with a >culture-positive case. For the 140 cases, 543 controls were selected. Of >the 140 cases, 29 (20.7%) received three doses of DTaP, 5 (3.6%) received >two doses of DTaP, 44 (31.4%) received two or three doses of DT vaccine, 44 >(31.4%) received one dose of either DTaP, whole-cell pertussis DTP or DT, >and 18 (13%) received no vaccine. Of the 543 controls, 175 (32.2%) received >three doses of DTaP, 67 (12.3%) received two doses of DTaP, 45 (8.3%) >received two or three doses of whole-cell pertussis DTP, 73 (13.4%) >received DT vaccine, 153 (28.2%) received one dose of either DT, DTP, or >DTaP, and 30 (5.5%) received no vaccine. Adjusting for sibling age, sibling >pertussis immunization by age group, siblings in day care, number of >siblings in day care, and father's employment status, the vaccine efficacy >of three doses of Tripedia® vaccine compared to two or three doses of DT >was 80% (95% CI; 59% to 90%). 1 > >In a clinical study conducted in 65 US and 89 German infants, a single lot >of Tripedia® vaccine was administered at 2, 4 and 6 months of age for the >purpose of comparing immune responses to PT and FHA. This study showed that >US and German infants, who received three doses of Tripedia® vaccine, >expressed similar antibody responses to these antigens. The percentage of >infants demonstrating a four-fold or greater antibody response, was also >similar for PT and FHA in both groups. 1 > >In a clinical study, US infants received Tripedia®, ActHIB®, OPV, and >hepatitis B vaccines simultaneously. In one of the study groups, Tripedia®, >ActHIB® and OPV were administered at 2, 4, and 6 months of age and >hepatitis B was given at 2 and 4 months of age. One hundred percent of the >69 children who received ActHIB® simultaneously with Tripedia® vaccine >demonstrated anti-PRP antibodies >/= 1 µg/mL. Sera from a subset of 12 >infants who received hepatitis B simultaneously at 2 and 4 months of age >showed that 93% had antiHBs titers of > 10 mIU/mL. Sera from a subset of 20 >infants who received OPV simultaneously at 2, 4, and 6 months of age showed >that 100% had protective neutralizing antibody responses to all three polio >virus types. > > > >TRIPEDIA® COMBINED WITH ActHIB®, TriHIBit®, BY RECONSTITUTION > > >Clinical studies examined the immune response in 15- to 20-month-old >children when Tripedia® vaccine was used to reconstitute one lyophilized >single dose vial of ActHIB® (TriHIBit®). All children received three doses >of Haemophilus b Conjugate Vaccine (ActHIB® or HibTITER®) and three doses >of whole-cell DTP at approximately 2, 4, and 6 months of age. Table 1 shows >the diphtheria, tetanus and pertussis responses when Tripedia® vaccine was >used to reconstitute ActHIB® (TriHIBit®) compared to the two vaccines given >concomitantly but at different sites. In children who received the vaccines >separately or combined, 100% had an antibody response to the PRP component >>/= 1.0 µg/mL. 1 > > > > > > > > > >TABLE 1 1 IMMUNE RESPONSES IN 15- TO 20-MONTH-OLD CHILDREN WHEN >TRIPEDIA® VACCINE IS COMBINED WITH ActHIB® BY RECONSTITUTION (TriHIBit®) >COMPARED TO THE VACCINES ADMINISTERED SEPARATELY > > PRE-DOSE POST-DOSE > VACCINE GROUP N </nurse/static.htm?path=pdrel/pdr/62470460.htm#F01>* >TriHIBit® >92-93 Separate >102-103 TriHIBit® >93 Separate >98 > Anti-LPF > GMT (ELISA units/mL) > % 4-Fold Rise 26.30 >- 24.56 >- 471.00 >87.0 363.90 >85.7 > Anti-LPF > GMT (CHO CELL) > % 4-Fold Rise 33.48 >- 31.78 >- 806.70 >92.3 701.60 >90.6 > Anti-FHA > GMT (ELISA units/mL) > % 4-Fold Rise 3.83 >- 3.61 >- 44.68 >68.5 </nurse/static.htm?path=pdrel/pdr/62470460.htm#F02>** 38.81 >80.6 > Diphtheria Antitoxin > GMT (units/mL) > > 0.01 u/mL 0.15 >- 0.16 >- 6.31 >100.00 6.65 >100.00 > Tetanus Antitoxin > GMT (equivalents/mL) > > 0.01 u/mL 0.05 >- 0.06 >- 1.10 >100.00 1.15 >100.00 > * N = number of children > ** The clinical significance of the difference in 4-fold rise of anti-FHA >is unknown at present. > > > >In clinical studies evaluating simultaneous administration of Tripedia® and >ActHIB® with MMR vaccine to 15- to 20-month-old children, the data suggest >that the combination vaccine does not interfere with the immunogenicity of >the MMR vaccine. Overall seroconversion rates in children who received >ActHIB® reconstituted with Tripedia® (TriHIBit®) vaccine were 98% (46/47), >98% (42/43) and 96% (43/45) for measles, mumps and rubella, respectively. > >(<JavaScript:GotoTop();>back to top) > > > >INDICATIONS AND USAGE > > >Tripedia® vaccine is indicated for active immunization against diphtheria, >tetanus and pertussis (whooping cough) simultaneously in infants and >children 6 weeks to 7 years of age (prior to seventh birthday). Because of >the substantial risks of complications of the disease, completion of a >primary series of pertussis vaccine early in life is strongly recommended. >3 However, in instances where the pertussis vaccine component is >contraindicated, Diphtheria and Tetanus Toxoids Adsorbed (For Pediatric >Use) (DT) should be used for each of the remaining doses. (See ></nurse/static.htm?path=pdrel/pdr/62470460.htm#T05>CONTRAINDICATIONS >section.) > >When Tripedia® vaccine is used to reconstitute ActHIB® (TriHIBit®), the >combined vaccines are indicated for the active immunization of children 15 >to 18 months of age who have previously been immunized against diphtheria, >tetanus and pertussis with three doses consisting of either whole-cell >pertussis DTP or acellular pertussis vaccine and three or fewer doses of >ActHIB® (OmniHIB®) within the first year of life for the prevention of >invasive diseases caused by H influenzae type b and caused by diphtheria, >tetanus, and pertussis. 1 (Refer to ActHIB® package insert.) > >If passive immunization is required, Tetanus Immune Globulin (Human) (TIG) >and/or equine Diphtheria Antitoxin should be used. > >Persons who have recovered from culture-confirmed pertussis do not need >additional doses of Tripedia® vaccine but should receive additional doses >of DT to complete the series. > >Tripedia® vaccine is not to be used for treatment of B. pertussis, C. >diphtheriae, or C. tetani infections. > >As with any vaccine, vaccination with Tripedia® vaccine may not protect >100% of susceptible individuals. > >(<JavaScript:GotoTop();>back to top) > > > >CONTRAINDICATIONS > > >Hypersensitivity to any component of the vaccine, including thimerosal and >gelatin, is a contraindication. > >It is a contraindication to use this vaccine after an immediate >anaphylactic reaction temporally associated with a previous dose. Because >of uncertainty as to which component of the vaccine might be responsible, >no further vaccination with diphtheria, tetanus, or pertussis components >should be carried out. Alternatively, because of the importance of tetanus >vaccination, such individuals may be referred for evaluation by an >allergist. 3 > >Immunization should be deferred during the course of an acute febrile >illness. The decision to administer or delay vaccination because of a >current or recent febrile illness depends on the severity of symptoms and >on the etiology of the disease. All vaccines can be administered to persons >with mild illness such as diarrhea, mild upper-respiratory infection with >or without low-grade fever, or other low grade febrile illness. 28 > >Elective immunization procedures should be deferred during an outbreak of >poliomyelitis. 29 > >Encephalopathy not due to an identifiable cause, occurring within 7 days of >a prior whole-cell pertussis DTP or DTaP immunization and consisting of >major alterations of consciousness, unresponsiveness, generalized or focal >seizures that persist for more than a few hours and failure to recover >within 24 hours should be considered a contraindication to further use; >this includes severe alterations in consciousness with generalized or focal >neurologic signs. Even though causation cannot be established, no >subsequent doses of pertussis vaccine should be given. 3 > >(<JavaScript:GotoTop();>back to top) > > > >WARNINGS > > >This product contains dry natural latex rubber as follows: The stopper to >the vial contains dry natural latex rubber. > >If any of the following events occurs in temporal relation with the receipt >of either whole-cell pertussis DTP or DTaP, the decision to administer >subsequent doses of vaccine containing the pertussis component should be >carefully considered. Although these events were once considered >contraindications to whole-cell pertussis DTP, there may be circumstances, >such as high incidence of pertussis, in which the potential benefits >outweigh the possible risks, particularly since the following events have >not been proven to cause permanent sequelae: 3,30 > > > * Temperature of >/= 40.5°C (105°F) within 48 hours, not due to another >identifiable cause. >* Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 >hours. >* Persistent, inconsolable crying lasting >/= 3 hours, occurring within 48 >hours. >* Convulsions with or without fever, occurring within 3 days. > >A recent clinical study suggests that persistent, inconsolable crying >lasting at least 3 hours following vaccination with Tripedia® vaccine may >occur less frequently than has been observed historically for DTP vaccine. >1,31 > >When a decision is made to withhold the pertussis component, immunization >with DT should be continued. > >Tripedia® vaccine should not be given to children with any coagulation >disorder, including thrombocytopenia, that would contraindicate >intramuscular injection unless the potential benefit clearly outweighs the >risk of administration. > >In the opinion of the manufacturer, seizure disorder in children before or >after any immunization with Tripedia® is considered a warning against >further immunization with this vaccine. Recent studies suggest that infants >and children with a history of convulsions in first-degree family members >(i.e., siblings and parents) have a 3.2-fold increased risk for neurologic >events compared with those without such histories when given DTP. 25,32 >However, the ACIP has concluded that a family history of convulsions in >parents and siblings is not a contraindication to pertussis vaccination and >that children with such family histories should receive pertussis vaccine >according to the recommended schedule. 3,20,28 > >In children with a history of febrile or non-febrile convulsions, >acetaminophen should be given at the time of Tripedia® vaccination >according to acetaminophen package insert recommended dosage to reduce the >possibility of post-vaccination fever. 3,20,28 > >A committee of the Institute of Medicine (IOM) has concluded that evidence >is consistent with a causal relationship between DTP and acute neurologic >illness, and under special circumstances, between DTP and chronic >neurologic disease in the context of the NCES report. 33,34 However, the >IOM committee concluded that the evidence was insufficient to indicate >whether or not DTP increased the overall risk of chronic neurologic >disease. 34 Acute encephalopathy or permanent neurological injury, have not >been reported in temporal association after administration of Tripedia® >vaccine but the experience with this vaccine is insufficient to rule this >out. (See </nurse/static.htm?path=pdrel/pdr/62470460.htm#V05>ADVERSE >REACTIONS section.) > >Infants and children with recognized possible or potential underlying >neurologic conditions seem to be at enhanced risk for the appearance of >manifestations of the underlying neurologic disorder within two or three >days following whole-cell pertussis vaccination. 3 Whether to administer >Tripedia® vaccine to children with proven or suspected underlying >neurologic disorders must be decided on an individual basis. Important >considerations include the current local incidence of pertussis. 3 > >Tripedia® vaccine should not be combined through reconstitution with any >vaccine for administration to infants younger than 15 months of age. >Tripedia® vaccine should not be reconstituted with any vaccine other than >ActHIB® (OmniHIB®) for children 15 months of age or older. > >(<JavaScript:GotoTop();>back to top) > > > >PRECAUTIONS > > > > >GENERAL > >Care is to be taken by the health-care provider for the safe and effective >use of this vaccine. > >EPINEPHRINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE SHOULD AN >ACUTE ANAPHYLACTIC REACTION OCCUR DUE TO ANY COMPONENT OF THE VACCINE. > >Prior to an injection of any vaccine, all known precautions should be taken >to prevent adverse reactions. This includes a review of the patient's >history with respect to possible sensitivity and any previous adverse >reactions to the vaccine or similar vaccines, and to possible sensitivity >to dry natural latex rubber, previous immunization history, current health >status (see ></nurse/static.htm?path=pdrel/pdr/62470460.htm#T05>CONTRAINDICATIONS >section), and a current knowledge of the literature concerning the use of >the vaccine under consideration. Immunosuppressed patients may not respond. >Tripedia® vaccine is not contraindicated in patients with HIV infection. 3 > >Special care should be taken to ensure that the injection does not enter a >blood vessel. > >A separate, sterile syringe and needle or a sterile disposable unit should >be used for each patient to prevent transmission of hepatitis or other >infectious agents from person to person. Needles should not be recapped but >should be disposed of properly. > > > > > >INFORMATION FOR PATIENT > >Parents should be fully informed of the benefits and risks of immunization >with Tripedia® vaccine. > >The physician should inform the parents or guardians about the potential >for adverse reactions that have been temporally associated with Tripedia® >and other pertussis vaccine administration. The health-care provider should >provide the Vaccine Information Materials (VIMs) which are required by the >National Childhood Vaccine Injury Act of 1986 to be given with each >immunization. Parents or guardians should be instructed to report any >serious adverse reactions to their health-care provider. > >IT IS EXTREMELY IMPORTANT WHEN A CHILD IS RETURNED FOR THE NEXT DOSE IN THE >SERIES THAT THE PARENT SHOULD BE QUESTIONED CONCERNING OCCURRENCE OF ANY >SYMPTOMS AND/OR SIGNS OF AN ADVERSE REACTION AFTER THE PREVIOUS DOSE OF THE >SAME VACCINE (SEE ></nurse/static.htm?path=pdrel/pdr/62470460.htm#T05>CONTRAINDICATIONS AND ></nurse/static.htm?path=pdrel/pdr/62470460.htm#V05>ADVERSE REACTIONS >SECTIONS). > >The health-care provider should inform the parent or guardian of the >importance of completing the pertussis immunization series, unless a >contraindication to further immunization exists. > >The US Department of Health and Human Services has established a Vaccine >Adverse Event Reporting System (VAERS) to accept all reports of suspected >adverse events after the administration of any vaccine, including but not >limited to the reporting of events required by the National Childhood >Vaccine Injury Act of 1986. 35 The toll-free number for VAERS forms and >information is 1-800-822-7967. > >The National Vaccine Injury Compensation Program, established by the >National Childhood Vaccine Injury Act of 1986, requires physicians and >other health-care providers who administer vaccines to maintain permanent >vaccination records and to report occurrences of certain adverse events to >the US Department of Health and Human Services. Reportable events include >those listed in the Act (i.e., those listed in the vaccine injury table) >for each vaccine and events specified in the package insert as >contraindications to further doses of the vaccine. 36,37 > >(<JavaScript:GotoTop();>back to top) > >DRUG INTERACTIONS > > >As with other IM injections use with caution in patients on anticoagulant >therapy. > >Immunosuppressive therapies, including irradiation, antimetabolites, >alkylating agents, cytotoxic drugs, and corticosteroids (used in greater >than physiologic doses), may reduce the immune response to vaccines. >Although no specific studies with pertussis vaccine are available, if >immunosuppressive therapy will be discontinued shortly, it would be >reasonable to defer immunization until the patient has been off therapy for >one month; otherwise, the patient should be vaccinated while still on >therapy. 3 > >For information regarding simultaneous administration with other vaccines >refer to </nurse/static.htm?path=pdrel/pdr/62470460.htm#G05>DOSAGE AND >ADMINISTRATION section. > >If Tripedia® vaccine has been administered to persons receiving >immunosuppressive therapy, a recent injection of immune globulin or having >an immunodeficiency disorder, an adequate immunologic response may not be >obtained. > >Tetanus Immune Globulin, or Diphtheria Antitoxin, if used, should be given >in a separate site, with a separate needle and syringe. > >The combination of Tripedia® vaccine with other vaccines has not been >evaluated for safety and immunogenicity in infants younger than 15 months >of age. The combination of Tripedia® vaccine with any vaccine other than >ActHIB® (OmniHIB®) has not been evaluated for safety and immunogenicity in >infants 15 months of age or older. > > > > > >CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY > >Tripedia® vaccine has not been evaluated for its carcinogenic or mutagenic >potentials or impairment of fertility. > > > >PREGNANCY > > >REPRODUCTIVE STUDIES--PREGNANCY CATEGORY C > >Animal reproduction studies have not been conducted with Tripedia® vaccine. >It is not known whether Tripedia® vaccine can cause fetal harm when >administered to a pregnant woman or can affect reproductive capacity. >Tripedia® vaccine is NOT recommended for use in a pregnant woman. > >PEDIATRIC USE > >SAFETY AND EFFECTIVENESS OF TRIPEDIA® VACCINE IN INFANTS BELOW SIX WEEKS OF >AGE HAVE NOT BEEN ESTABLISHED. (SEE ></nurse/static.htm?path=pdrel/pdr/62470460.htm#G05>DOSAGE AND >ADMINISTRATION SECTION.) > >THIS VACCINE IS NOT RECOMMENDED FOR PERSONS 7 YEARS OF AGE AND OLDER. >Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (Td) is to be used in >individuals 7 years of age or older. > >Tripedia® vaccine should not be combined through reconstitution with any >vaccine for administration to infants younger than 15 months of age. >Tripedia® vaccine can only be combined with ActHIB® (OmniHIB®) by >reconstitution for children 15 months of age or older. > >(<JavaScript:GotoTop();>back to top) > > > >ADVERSE REACTIONS > > >A total of 11,400 doses of Tripedia® vaccine has been administered in US >clinical trials in children 2 to 6 months, 15 to 20 months of age or 4 to 6 >years of age. When compared to CLI's whole-cell pertussis DTP vaccine, >Tripedia® vaccine produced fewer local reactions such as erythema, >swelling, and tenderness at the injection site and fewer systemic reactions >such as fever, irritability, drowsiness, vomiting, anorexia and >high-pitched unusual cry. 1 In a double-blind, comparative US trial, 673 >infants were randomized to receive either 3 doses of Tripedia® vaccine or >CLI's DTP vaccine (Table 2). 1 Safety data are available for 672 infants. >Rates for all reported local reactions and other reactions such as fever > >101°F, irritability, drowsiness, and anorexia were significantly less in >Tripedia® vaccine recipients. In contrast to whole-cell pertussis DTP, no >hypotonic-hyporesponsive episodes occurred in Tripedia® vaccine recipients. >Reaction rates generally peaked within the first 24 hours, and decreased >substantially over the next two days. 1,14,15 > > > > > > > > > >TABLE 2 1 ADVERSE EVENTS OCCURRING WITHIN 72 HOURS FOLLOWING DIPHTHERIA >AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS VACCINE ADSORBED TRIPEDIA®) >IMMUNIZATIONS GIVEN TO INFANTS 2 TO 6 MONTHS OF AGE > > FREQUENCY > EVENT TRIPEDIA® >REACTION % WHOLE-CELL PERTUSSIS DTP >REACTION % > Dose 1 Dose 2 Dose 3 Dose 1 Dose 2 Dose 3 > No. of Infants </nurse/static.htm?path=pdrel/pdr/62470460.htm#F05>**/* >505 499 490 167 159 152 > Local > Erythema </nurse/static.htm?path=pdrel/pdr/62470460.htm#F03>* 9.0 9.8 >16.9 28.3 32.9 32.9 > Erythema > 1 " </nurse/static.htm?path=pdrel/pdr/62470460.htm#F03>* 1.2 > 1.8 2.2 7.8 8.4 7.4 > Swelling </nurse/static.htm?path=pdrel/pdr/62470460.htm#F03>* 6.4 4.5 >6.5 28.3 23.9 27.5 > Swelling > 1 " </nurse/static.htm?path=pdrel/pdr/62470460.htm#F03>* 1.4 > 0.6 1.0 12.7 11.0 11.4 > Tenderness </nurse/static.htm?path=pdrel/pdr/62470460.htm#F03>* 11.8 >6.7 7.1 50.6 44.2 42.6 > Systemic > Fever > 101°F (rectal) ></nurse/static.htm?path=pdrel/pdr/62470460.htm#F03>* 0.4 1.6 3.5 3.6 >7.5 11.2 > Irritability </nurse/static.htm?path=pdrel/pdr/62470460.htm#F03>* 35.3 >30.1 27.1 72.9 71.8 57.7 > Drowsiness </nurse/static.htm?path=pdrel/pdr/62470460.htm#F03>* 39.4 >17.6 15.9 59.6 45.2 25.5 > Anorexia </nurse/static.htm?path=pdrel/pdr/62470460.htm#F03>* 6.0 5.3 >5.7 26.5 20.0 18.8 > Vomiting 6.0 </nurse/static.htm?path=pdrel/pdr/62470460.htm#F04>** 5.5 > 3.7 10.8 7.1 2.7 > High-pitched cry 2.4 1.0 1.4 10.8 5.8 3.4 > Persistent cry 0.2 0.2 0.8 3.0 1.3 2.0 > * p < 0.01 when compared to whole-cell pertussis DTP for all doses. > ** p < 0.05 when compared to whole-cell pertussis DTP. > **/* For certain adverse events information was not available for a small >number of infants. > > > >Adverse event data for Tables 2-6 were actively collected using patient >diaries, phone call follow-up and/or by questioning the parent(s) at clinic >visits. All data were recorded on standardized case report forms. > >A similar reduction in adverse events was seen in a randomized, >double-blind, comparative trial conducted in the US by the National >Institutes of Health (NIH) when Tripedia® vaccine was compared to Lederle >Laboratories whole-cell pertussis DTP vaccine (Table 3). 38 Each data point >presented in Table 3 is a summary of the frequency of reactions following >any of the three primary immunizing doses. Local adverse reactions which >include pain, erythema, swelling, and systemic reactions such as fever, >anorexia, vomiting, drowsiness and fussiness may occur following any of the >three primary vaccinations. > > > > > > > > > >TABLE 3 38 PERCENT OF INFANTS WHO WERE REPORTED TO HAVE HAD THE >INDICATED REACTION BY THE THIRD EVENING AFTER ANY OF THE FIRST THREE DOSES >OF WHOLE-CELL PERTUSSIS DTP OR DTaP > > N </nurse/static.htm?path=pdrel/pdr/62470460.htm#F10>¶ ERYTHEMA >SWELLING PAIN </nurse/static.htm?path=pdrel/pdr/62470460.htm#F08>**/* >FEVER </nurse/static.htm?path=pdrel/pdr/62470460.htm#F06>* >>101°F ANOREXIA VOMITING DROWSINESS FUSSINESS ></nurse/static.htm?path=pdrel/pdr/62470460.htm#F09>**/** > Tripedia® 135 32.6 ></nurse/static.htm?path=pdrel/pdr/62470460.htm#F07>** 20.0 ></nurse/static.htm?path=pdrel/pdr/62470460.htm#F07>** 9.6 ></nurse/static.htm?path=pdrel/pdr/62470460.htm#F07>** 5.2 ></nurse/static.htm?path=pdrel/pdr/62470460.htm#F07>** 22.2 ></nurse/static.htm?path=pdrel/pdr/62470460.htm#F07>** 7.4 41.5 ></nurse/static.htm?path=pdrel/pdr/62470460.htm#F07>** 19.3 ></nurse/static.htm?path=pdrel/pdr/62470460.htm#F07>** > Whole-Cell > Pertussis DTP 371 72.7 60.9 40.2 15.9 35.0 13.7 62.0 41.5 > * Rectal Temperatures > **p < 0.01 when compared to whole-cell pertussis DTP. > **/* Moderate or severe = cried or protested to touch or when leg moved. > **/** Moderate or severe = prolonged or persistent crying that could not >be comforted and refusal to play. > ¶ N = Number of infants > > > >The frequency of adverse reactions following each dose in children who >received only Tripedia® vaccine is shown in Table 4. 1,38 Of the 135 >infants who received Tripedia® vaccine at 2, 4, and 6 months of age, a >subset of 82 received a fourth dose of Tripedia® vaccine and a subset of 18 >received a fifth dose of Tripedia® vaccine. > > > > > > > > > >TABLE 4 1,38 ADVERSE EVENTS (%) OCCURRING WITHIN 72 HOURS FOLLOWING EACH >DOSE OF DIPHTHERIA AND TETANUS TOXOID AND ACELLULAR PERTUSSIS VACCINE >(TRIPEDIA®) VACCINATION IN CHILDREN IN WHICH ALL DOSES WERE TRIPEDIA® VACCINE > > > > >EVENT > PRIMARY >(N = 135 INFANTS) BOOSTER >(N = 82 CHILDREN) >(N = 18 CHILDREN) > DOSE 1 >2 Months DOSE 2 >4 Months DOSE 3 >6 Months DOSE 4 >15 to 20 Months DOSE 5 >4 to 6 Years > Local > Erythema 12.6 12.7 19.1 17.1 33.3 > Swelling 8.8 8.2 10.7 15.9 27.8 > Pain </nurse/static.htm?path=pdrel/pdr/62470460.htm#F11>* 8.1 3.7 2.3 > 7.3 11.1 > Systemic > Fever > 101°F </nurse/static.htm?path=pdrel/pdr/62470460.htm#F13>**/* >0.7 1.4 3.1 2.4 0 > Anorexia 8.1 9.7 9.9 8.5 0 > Vomiting 5.2 1.5 2.3 2.4 0 > Drowsiness 28.9 17.9 4.6 6.1 5.6 > Fussiness </nurse/static.htm?path=pdrel/pdr/62470460.htm#F12>** 8.1 >7.4 7.6 3.7 0 > * Moderate or severe = cried or protested to touch or when leg moved. > ** Moderate or severe = prolonged or persistent crying that could not be >comforted and refusal to play. > **/* Rectal temperatures for primary series, oral temperatures for Dose 4 >and Dose 5. > > > >In an open label US study additional data are available in 15- to >20-month-old children who had previously received three doses of either >Tripedia® vaccine (n = 109) or whole-cell pertussis DTP (n = 30). 39 >Reaction rates are presented in Table 5. Data on 738 children (a subset of >the German case control study) receiving a fourth dose of Tripedia® vaccine >in an open label study showed local and systemic reaction rates in the day >following vaccination as follows: erythema (36.7%), erythema > 1 inch >(12.5%), swelling (20.2%), pain (14%), temperature >/= 100.4°F (10.6%), >irritability (14.6%), anorexia (8.4%), and persistent crying > 3 hours >(0.4%). 1 > > > > > > > > > >TABLE 5 1,39 COMPARISON OF ADVERSE EVENTS (%) OCCURRING WITHIN 72 HOURS >FOLLOWING VACCINATION WITH >TRIPEDIA® VACCINE IN CHILDREN WHO HAD RECEIVED THREE PREVIOUS DOSES OF >TRIPEDIA® VACCINE OR THREE DOSES >OF WHOLE-CELL PERTUSSIS DTP > > N ERY- >THEMA >>/=1 INCH SWELL- >ING >>/=1 INCH PAIN TEMPER- >ATURE >>/= >101°F IRRIT- >ABIL- >ITY > Tripedia® Primed 109 30.3 29.4 19.3 5.5 19.3 > Whole-Cell pertussis > DTP Primed 30 23.3 20.0 10.3 3.3 13.3 > > > >Table 6 lists the frequency of adverse reactions in 372 US children who >received Tripedia® vaccine at 15 to 20 months of age and 240 US children >who received Tripedia® vaccine at 4 to 6 years of age in a study conducted >from 1989-1990. These children had previously received three or four doses >of whole-cell pertussis DTP vaccine at approximately 2, 4, 6, and 18 months >of age. 1 > > > > > > > > > >TABLE 6 1 ADVERSE EVENTS (%) OCCURRING WITHIN 72 HOURS FOLLOWING DIPHTHERIA >AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS VACCINE ADSORBED (TRIPEDIA®) >IMMUNIZATIONS GIVEN AT 15 TO 20 MONTHS AND 4 TO 6 YEARS OF AGE IN CHILDREN >WHO HAD RECEIVED THREE OR FOUR DOSES OF DTP > > > >EVENT > 15 TO 20 MONTHS >THREE PREVIOUS >DTP DOSES >REACTION % >(N = 372 CHILDREN) 4 TO 6 YEARS >FOUR PREVIOUS >DTP DOSES >REACTION % >(N = 240 CHILDREN) > Local > Erythema </nurse/static.htm?path=pdrel/pdr/62470460.htm#F14>* 18.3 31.3 > Swelling </nurse/static.htm?path=pdrel/pdr/62470460.htm#F15>** 10.8 >27.9 > Tenderness 14.2 46.2 > Systemic > Fever > 101°F 4.7 4.8 > Diarrhea 6.3 0.8 > Vomiting 2.2 1.7 > Anorexia 7.8 5.4 > Drowsiness 12.4 15.0 > Irritability 21.2 15.8 > High-pitched > unusual cry 1.1 </nurse/static.htm?path=pdrel/pdr/62470460.htm#F16>NA > * Includes all occurrences of erythema. > ** Includes all occurrences of swelling. > NA Data not collected in this age group. > > > >The results of an open label, non-controlled clinical study, of 2,457 US >children and targeted to evaluate less common and more severe adverse >events following three doses of Tripedia® vaccine in the primary series are >shown in Table 7. 1 Data were collected by parental interview at subsequent >immunizations, chart review and telephone calls to the parents 60 days >after the third dose. > > > > > > > > > >TABLE 7 1 MODERATELY SEVERE ADVERSE EVENTS OCCURRING WITHIN 48 HOURS >FOLLOWING VACCINATION WITH TRIPEDIA® AT 2, 4, OR 6 MONTHS OF AGE (N = 7,102 >DOSES) > > EVENT NUMBER RATE/ >1,000 >DOSES > Fever >/= 105°F 2 0.28 > Hypotonic/ > Hyporesponsive > Episode 1 0.14 > Persistent cry > >/= 3 hours 4 0.56 > Convulsions </nurse/static.htm?path=pdrel/pdr/62470460.htm#F17>* 0 0 > *One seizure episode was noted between 48 and 72 hours. > > > >Adverse experiences that are more serious and less common than those >reported in Table 7 are not known at this time. > >In the large German efficacy study that enrolled 16,780 infants, 12,514 of >whom received 41,615 doses of Tripedia® vaccine, hospitalization rates and >death rates were similar between Tripedia® vaccine and DT recipients. 1 >Adverse events were monitored by spontaneous reporting by parents and a >medical history obtained at each subsequent vaccination. Adverse events >(rates per 1,000 doses) occurring within 7 days including those events >interpreted by the investigator as related as well as those interpreted as >unrelated to vaccination included; unusual cry (0.96), persistent cry > 3 >hours (0.12), febrile seizure (0.05), afebrile seizure (0.02) and >hypotonic/hyporesponsive episodes (0.05). In contrast to the first Swedish >pertussis efficacy trial conducted in 1986-87, 10 no deaths due to invasive >bacterial infections were reported. > >Rarely, an anaphylactic reaction (i.e., hives, swelling of the mouth, >difficulty breathing, hypotension, or shock) has been reported after >receiving preparations containing diphtheria, tetanus, and/or pertussis >antigens. 3 > >Arthus-type hypersensitivity reactions, characterized by severe local >reactions (generally starting 2 to 8 hours after an injection), may follow >receipt of tetanus toxoid. A few cases of peripheral neuropathy have been >reported following tetanus toxoid administration, although the evidence is >inadequate to accept or reject a causal relation. 40 > >Whole-cell pertussis DTP has been associated with acute encephalopathy. 33 >A 10-year follow-up to the National Childhood Encephalopathy Study (NCES) >of children who experienced acute neurologic disorders in infancy concluded >that serious acute neurologic illness increased the risk of chronic >neurologic disease or death. 41 A committee of the Institute of Medicine >(IOM) has concluded that, because DTP may cause acute neurologic illness, >DTP may also cause chronic neurologic disease in the context of the NCES >report. 34 However the IOM committee concluded that the evidence was >insufficient to indicate whether or not DTP increased the overall risk of >chronic neurologic disease. 34 > >Sudden Infant Death Syndrome (SIDS) has occurred in infants following >administration of whole-cell pertussis DTP and DTaP. Large case-control >studies of SIDS in the US have shown that receipt of whole-cell pertussis >DTP was not causally related to SIDS. 42,43,44 It should be recognized that >the first three primary immunizing doses of whole-cell pertussis DTP and >DTaP are usually administered to infants 2 to 6 months old and that >approximately 85% of SIDS cases occur at ages 1 to 6 months, with the peak >incidence occurring at 6 weeks to 4 months of age. By chance alone, some >cases of SIDS can be expected to follow receipt of whole-cell pertussis DTP >44 and DTaP. A review by a committee of the IOM concluded that available >evidence did not indicate a causal relation between DTP vaccine and SIDS. 33 > >Onset of infantile spasms has occurred in infants who have recently >received DTP or DT. Analysis of data from the NCES on children with >infantile spasms showed that receipt of DT or DTP was not causally related >to infantile spasms. 45 The incidence of onset of infantile spasms >increases at 3 to 9 months of age, the time period in which the second and >third doses of DTP are generally given. Therefore, some cases of infantile >spasms can be expected to be related by chance alone to recent receipt of >DTP. 3 > >A bulging fontanelle associated with increased intracranial pressure which >occurred within 24 hours following DTP immunization has been reported, >although a causal relationship has not been established. 33,46,47,48 > >The above findings regarding possible association of unusual neurologic >events and SIDS relate only to DTP vaccine containing whole-cell pertussis. >At this time there are insufficient data to determine their relevance to >Tripedia® vaccine. > >A review by the IOM found a causal relation between tetanus toxoid and >brachial neuritis and Guillain-Barré syndrome. 40 The following illnesses >have been reported as temporally associated with vaccine containing tetanus >toxoid: neurological complications 49,50 including cochlear lesion, 51 >brachial plexus neuropathies, 51,52 paralysis of the radial nerve, 53 >paralysis of the recurrent nerve, 51 accommodation paresis, and EEG >disturbances with encephalopathy. 17 In the differential diagnosis of >polyradiculoneuropathies following administration of a vaccine containing >tetanus toxoid, tetanus toxoid should be considered as a possible etiology. >54,55 > >In the German case-control study and US open-label safety study in which >14,971 infants received Tripedia® vaccine, 13 deaths in Tripedia® vaccine >recipients were reported to study investigators. Causes of deaths included, >seven SIDS, and one of each of the following; enteritis, Leigh Syndrome, >adrenogenital syndrome, cardiac arrest, motor vehicle accident and >accidental drowning. None of these events were determined to be >vaccine-related and all occurred more than two weeks past immunization. 1 >The rate of SIDS observed in the German case-control study was 0.4/1,000 >vaccinated infants. The rate of SIDS observed in the US open-label safety >study was 0.8/1,000 vaccinated infants and the reported rate of SIDS in the >US from 1985-1991 was 1.5/1,000 live births. 56 By chance alone, some cases >of SIDS can be expected to follow receipt of whole-cell pertussis DTP 44 >and DTaP. > >In the Swedish efficacy trial where 1,419 recipients received the pertussis >components in Tripedia® vaccine, three deaths due to invasive bacterial >infections occurred. Further investigation revealed no evidence for a >causal relation between vaccination and altered resistance to invasive >disease caused by encapsulated bacteria. 11 While the hypothesis that the >two variables are related cannot be ruled out in the Swedish trial, deaths >due to invasive bacterial infections have been monitored in other trials. >In contrast to the Swedish trial, in the German case-control study and US >open-label safety study, 14,971 infants received Tripedia® vaccine and no >deaths due to invasive bacterial infections were reported. > >When Tripedia® vaccine was used to reconstitute ActHIB® (TriHIBit®) and >administered to children 15 to 20 months of age, the systemic adverse >experience profile was comparable to that observed when the two vaccines >were given separately. An increase in rates of minor local reactions was >observed within the 24-hour period after immunization when compared to the >Tripedia® and ActHIB® (OmniHIB®) vaccines administered separately. However, >local adverse event rates of the combined vaccines were comparable when >taking into consideration reactions observed at the ActHIB® site. 1 (Refer >to ActHIB® package insert; Table 7.) > > > >Reporting of Adverse Events > > >Reporting by parents and patients of all adverse events occurring after >vaccine administration should be encouraged. Adverse events following >immunization with vaccine should be reported by the health-care provider to >the US Department of Health and Human Services (DHHS) Vaccine Adverse >Events Reporting System (VAERS). Reporting forms and information about >reporting requirements or completion of the form can be obtained from VAERS >through a toll-free number 1-800-822-7967. 35,36,37 > >The health-care provider also should report these events to the Director of >Medical Affairs, Connaught Laboratories, Inc., a Pasteur Mérieux Connaught >Company, Discovery Drive, Swiftwater, PA 18370-0187 or call 1-800-822-2463. > >(<JavaScript:GotoTop();>back to top) > > > >DOSAGE AND ADMINISTRATION > > >Parenteral drug products should be inspected visually for extraneous >particulate matter and/or discoloration prior to administration whenever >solution and container permit. If these conditions exist, the vaccine >should not be administered. > >SHAKE VIAL WELL before withdrawing each dose. Inject 0.5 mL of Tripedia® >vaccine intramuscularly only. The preferred injection sites are the >anterolateral aspect of the thigh and the deltoid muscle of the upper arm. >The vaccine should not be injected into the gluteal area or areas where >there may be a major nerve trunk. > >The primary series for children less than 7 years of age is three >intramuscular doses of 0.5 mL. The customary age for the first dose is 2 >months of age but may be given as early as 6 weeks of age and up to the >seventh birthday. > >Before injection, the skin over the site to be injected should be cleansed >with a suitable germicide. After insertion of the needle, aspirate to >ensure that the needle has not entered a blood vessel. > >Fractional doses (doses < 0.5 mL) should not be given. The effect of >fractional doses on the frequency of serious adverse events and on efficacy >has not been determined. > >Do NOT administer this product subcutaneously. > > > > > >PRIMARY IMMUNIZATION > >The primary series consists of three doses administered at intervals of 4 >to 8 weeks. It is recommended that Tripedia® vaccine be given for all three >doses since no interchangeability data on DTaP vaccines exist for the >primary series. > >Tripedia® vaccine may be used to complete the primary series in infants who >have received one or two doses of whole-cell pertussis DTP. However, the >safety and efficacy of Tripedia® vaccine in such infants has not been >evaluated. > >Tripedia® vaccine should not be combined through reconstitution with any >other vaccine for administration to infants younger than 15 months of age. >There are insufficient data at this time to support the use of Tripedia® >vaccine to reconstitute ActHIB® (TriHIBit®) for primary immunization. > > > > > >BOOSTER IMMUNIZATION > >When Tripedia® vaccine is given for the primary series, a fourth dose is >recommended at 15 to 20 months of age. The interval between the third and >fourth dose should be at least 6 months. At this time, data are >insufficient to establish frequencies of adverse events following a fifth >dose of Tripedia® vaccine in children who have previously received 4 doses >of Tripedia® vaccine. (See ></nurse/static.htm?path=pdrel/pdr/62470460.htm#V05>ADVERSE REACTIONS >section.) > >If a child receives whole-cell pertussis DTP for one or more doses, >Tripedia® vaccine may be given to complete the five-dose series. A fourth >dose is recommended at 15 to 20 months of age. The interval between the >third and fourth dose should be at least 6 months. Children four to six >years of age (up to the seventh birthday) who received all four doses by >the fourth birthday, including one or more doses of whole-cell pertussis >DTP, should receive a single dose of Tripedia® vaccine before entering >kindergarten or elementary school. This dose is not needed if the fourth >dose was given on or after the fourth birthday. > >Tripedia® vaccine combined with ActHIB® (TriHIBit®) by reconstitution, may >be administered at 15 to 18 months of age for the fourth dose. (Refer to >ActHIB® package insert.) > >Tripedia® vaccine may be administered according to any of the following >schedules for infants and children 6 weeks through 6 years of age (up to >the 7th birthday). > > > > > > > > >Primary series > >* Three doses administered at intervals of 4 to 8 weeks, beginning at 6 >weeks of age >* To complete the primary series for infants who have received one or two >doses of DTP > >Booster doses > >* As a 4th and/or 5th dose following a primary series of three doses of DTP >* As a 4th dose following a primary series of Tripedia® vaccine* >* As a 4th dose when used to reconstitute ActHIB® (TriHIBit®)** > > > > > > > >*Data are insufficient to establish frequencies of adverse events following >a fifth dose of Tripedia® vaccine in children who have previously received >four doses of Tripedia® vaccine. > >**Tripedia® vaccine should not be combined through reconstitution with any >other vaccine. > >If any recommended dose of pertussis vaccine cannot be given, DT (For >Pediatric Use) should be given as needed to complete the series. > >PERSONS 7 YEARS OF AGE AND OLDER SHOULD NOT BE IMMUNIZED WITH TRIPEDIA® >VACCINE. 28 > >Preterm infants should be vaccinated according to their chronological age >from birth. 20 > >Interruption of the recommended schedule with a delay between doses should >not interfere with the final immunity achieved with Tripedia® vaccine. >There is no need to start the series over again, regardless of the time >between doses. > >Routine simultaneous administration of DTaP, OPV (or IPV), Haemophilus b >conjugate vaccine, MMR, and hepatitis B vaccine is encouraged for children >who are the recommended age to receive these vaccines and for whom no >specific contraindications exist at the time of the visit, unless, in the >judgment of the provider, complete vaccination of the child will not be >compromised by administering different vaccines at different visits. >Simultaneous administration is particularly important if the child might >not return for subsequent vaccinations (see ></nurse/static.htm?path=pdrel/pdr/62470460.htm#K05>CLINICAL PHARMACOLOGY >section). 28 > >Data are unavailable to the manufacturer concerning the effects on immune >response of IPV when given concurrently with ActHIB® reconstituted with >Tripedia® (TriHIBit®). > >If passive immunization is needed for tetanus prophylaxis, Tetanus Immune >Globulin (Human) (TIG) is the product of choice. It provides longer >protection than antitoxin of animal origin and causes few adverse >reactions. The currently recommended prophylactic dose of TIG for wounds of >average severity is 250 units intramuscularly. When tetanus toxoid and TIG >are administered concurrently, separate syringes and separate sites should >be used. The ACIP recommends the use of only adsorbed toxoid in this >situation. > >(<JavaScript:GotoTop();>back to top) > > > >HOW SUPPLIED > > >Vial, 1 Dose (5 per package) - Product No. 49281-288-05 > >Vial, 15 Dose (7.5 mL) - Product No. 49281-288-15 > >TriHIBit®, One 7.5 mL vial of Tripedia® vaccine as Diluent packaged with >Ten 1 Dose vials of lyophilized ActHIB® - Product No. 49281-557-10 > >TriHIBit®, Five 0.6 mL vials of Tripedia® vaccine as Diluent packaged with >Five 1 Dose vials of lyophilized ActHIB® - Product No. 49281-557-05 > > > >STORAGE > > >Store between 2°-8°C (35°-46°F). DO NOT FREEZE. Temperature extremes may >adversely affect resuspendability of this vaccine. > >(<JavaScript:GotoTop();>back to top) > >PRODUCT PHOTO(S): > >NOTE: These photos can be used only for identification by shape, color, and >imprint. They do not depict actual or relative size. > >The product samples shown here have been supplied by the manufacturer and >reproduced in full color by PDR as a quick-reference identification aid. >While every effort has been made to assure accurate reproduction, please >remember that any visual identification should be considered preliminary. >In cases of poisoning or suspected overdosage, the drug's identity should >be verified by chemical analysis. > >---------- > > > >---------- >(<JavaScript:GotoTop();>back to top) > > > > > >REFERENCES > > > > * Unpublished data available from Connaught Laboratories, Inc. >* Mueller JH, et al. Production of diphtheria toxin of high potency (100 >Lf) on a reproducible medium. J Immunol 40: 21-32, 1941 >* Recommendations of the Advisory Committee of Immunization Practices >(ACIP). Diphtheria, Tetanus, and Pertussis: Recommendations for vaccine use >and other preventive measures. MMWR 40: No RR-10, 1991 >* Kimura M, et al. Developments in pertussis immunisation in Japan. The >Lancet: 30-32, 1990 >* Kimura M, et al. Current epidemiology of pertussis in Japan. Pediatr >Infect Dis J 9: 705-709, 1990 >* Aoyama T, et al. Efficacy and immunogenicity of acellular pertussis >vaccine by manufacturer and patient age. Amer J Dis Child 143: 655-659, 1989 >* Aoyama T, et al. Efficacy of an acellular pertussis vaccine in Japan. J >Pediatr 107: 180-183, 1985 >* Blennow M, et al. Preliminary data from a clinical trial (phase 2) of an >Acellular Pertussis Vaccine, J NIH-6. Develop Biol Standard 65: 185-190, 1986 >* Blennow M, et al. Primary immunization of infants with an Acellular >Pertussis Vaccine in a double-blind randomized clinical trial. Pediatr 82: >293-299, 1988 >* Kallings LO, et al. Placebo-controlled trial of two Acellular Pertussis >Vaccines in Sweden - protective efficacy and adverse events. Lancet: >955-960, 1988 >* Storsaeter J, et al. Mortality and morbidity from invasive bacterial >infections during a clinical trial of acellular pertussis vaccines in >Sweden. Pediatr Infect Dis J 7: 637-645, 1988 >* Bernstein H, et al. Clinical reactions and immunogenicity of the BIKEN >Acellular Diphtheria and Tetanus Toxoids and Pertussis Vaccine in 4- >through 6-year-old US children. Amer J Dis Child 146: 556-559, 1992 >* Feldman S, et al. Comparison of acellular (B-Type) and whole-cell >pertussis-component diphtheria-tetanus-pertussis vaccines as the first >booster immunization in 15- to 24-month old children. J Pediatr 121: >857-861, 1992 >* Feldman S, et al. Comparison of two-component acellular and standard >whole-cell pertussis vaccines, combined with diphtheria-tetanus toxoids, as >the primary immunization series in infants. South Med J 86: 269-275, 284, >1993 >* Pichichero ME, et al. Acellular pertussis vaccination of 2-month-old >infants in the United States. J Pediatr 89: 882-887, 1992 >* CDC. Summary of Notifiable Disease, United States, 1994. MMWR 43: No. 53, >1995 >* CDC. Diphtheria Epidemic - New Independent States of the Former Soviet >Union, 1990-1994. MMWR 44: 177-181, 1995 >* Department of Health and Human Services, Food and Drug Administration. >Biological Products; Bacterial Vaccines and Toxoids; Implementation of >Efficacy Review; Proposed Rule. Federal Register Vol 50 No 240, pp >51002-51117, 1985 >* CDC - Pertussis - United States, January 1992-June 1995. MMWR 44: >525-529, 1995 >* Report of the Committee on Infectious Diseases. American Academy of >Pediatrics, ton, Illinois. Twenty-third Edition, 1994 >* Farizo KM, et al. Epidemiologic features of pertussis in the United >States, 1980-1989. Clin Infect Dis 14: 708-719, 1992 >* Nennig ME, et al. Prevalence and Incidence of Adult Pertussis in an Urban >Population. JAMA (21) 275: 1672-1674, 1996 >* Linnemann CC, et al. Pertussis in the adult. Ann Rev Med 28: 179-185, 1977 >* CDC. Pertussis Surveillance - United States, 1986 and 1988. MMWR 39: >57-66, 1990 >* Noble GR, et al. Acellular and whole-cell pertussis vaccines in Japan. >JAMA 257: 1351-1356, 1987 >* Blackwelder WC, et al., Acellular Pertussis Vaccines. Efficacy and >evaluation of clinical case definitions. Am J Dis Child: 145 (11): >1285-1289, 1991 >* Olin P, et al. Relative efficacy of two acellular pertussis vaccines >during three years of passive surveillance. Vaccine 10: pp 142-144, 1992 >* ACIP. General recommendations on immunization. MMWR 43: No. RR-1, 1994 >* GS. The Hazards of Immunization. Provocation poliomyelitis. pp >270-274, 1967 >* ACIP. Pertussis Vaccination: Acellular Pertussis Vaccine for Reinforcing >and Booster Use - Supplementary ACIP Statement. MMWR 41: No. RR-1, 1992 >* Cody CL, et al. Nature and rates of adverse reactions associated with DTP >and DT immunizations in infants and children. Pediatr 68: 650-660, 1981 >* ACIP. Pertussis immunization: Family history of convulsions and use of >antipyretics - Supplementary ACIP statement. MMWR 36: 281-282, 1987 >* Howson CP, et al. Adverse Effects of Pertussis and Rubella Vaccines, >Pertussis Vaccines and CNS Disorders. Institute of Medicine (IOM). National >Academy Press, Washington, DC, 1991 >* IOM. DTP vaccine and chronic nervous system dysfunction: a new analysis. >National Academy Press, Washington, DC, 1994 (Supplement) >* CDC. Vaccine Adverse Event Reporting System - United States. MMWR 39: >730-733, 1990 >* CDC. National Childhood Vaccine Injury Act: requirements for permanent >vaccination records and for reporting of selected events after vaccination. >MMWR 37: 197-200, 1988 >* Food and Drug Administration. New reporting requirements for vaccine >adverse events. FDA Drug Bull 18 (2), 16-18, 1988 >* Decker MD, et al. Comparison of 13 Acellular Pertussis Vaccines: Adverse >Reactions. Pediatr 96: 557-566, 1995 >* Pichichero ME, et al. Safety and immunogenicity of an acellular pertussis >vaccine booster in 15- to 20-month-old children previously immunized with >acellular or whole-cell pertussis vaccine as infants. Pediatr 91: 756-760, >1993 >* Stratton KR, et al. Adverse Events Associated with Childhood Vaccines. >Evidence Bearing on Causality. IOM. National Academy Press. Washington, DC, >1994 >* D, et al. Pertussis immunization and serious acute neurological >illnesses in children. Academic Department of Public Health, St 's >Hospital Medical School, University of London, 1993 >* MR, et al. Risk of sudden infant death syndrome after >immunization with Diphtheria-Tetanus-Pertussis Vaccine. N Engl J Med >618-623, 1988 >* Hoffman HJ, et al. Diphtheria-tetanus-pertussis immunization and sudden >infant death: Results of the National Institute of Child Health and Human >Development ative Epidemiological Study of Sudden Infant Death >Syndrome Risk Factors. Pediatr 79: 598-611, 1987 >* AM, et al. Diphtheria-tetanus-pertussis immunization and sudden >infant death syndrome. Am J Public Health 77: 945-951, 1987 >* Bellman MH, et al. Infantile spasms and pertussis immunization. Lancet, >i: 1031-1034, 1983 >* J, et al. Increased intracranial pressure after diphtheria, tetanus >and pertussis immunization. Am J Dis Child Vol 133: 217-218, 1979 >* Mathur R, et al. Bulging fontanel following triple vaccine. Indian >Pediatr 18 (6): 417-418, 1981 >* Shendurnikar N, et al. Bulging fontanel following DTP vaccine. Indian >Pediatr 23 (11): 960, 1986 >* Rutledge SL, et al. Neurological complications of immunizations. J >Pediatr 109: 917-924, 1986 >* AM, et al. Neurologic events following >diphtheria-tetanus-pertussis immunization. Pediatr 81: 345-349, 1988 >* GS. The Hazards of Immunization. Allergic manifestations: >Post-vaccinal neuritis. pp 153-156, 1967 >* Tsairis P, et al. Natural history of brachial plexus neuropathy. Arch >Neurol 27: 109-117, 1972 >* Blumstein GI, et al. Peripheral neuropathy following tetanus toxoid >administration. JAMA 198: 1030-1031, 1966 >* CDC. Adverse events following immunization. Surveillance Report No. 3, >1985-1986, Issued February 1989 >* Schlenska GK. Unusual neurological complications following tetanus toxoid >administration. J Neurol 215: 299-302, 1977 >* Willinger M, et al. Infant Sleep Position and Risk for Sudden Infant >Death Syndrome: Report of Meeting Held January 13 and 14, 1994, National >Institutes of Health, Bethesda, MD. Pediatr 93: 814-819, 1994 > >Product information as of September 1996 > >Manufactured by: > >CONNAUGHT LABORATORIES, INC. > >Swiftwater, Pennsylvania 18370-0187, USA > >and > >The Research Foundation for Microbial > >Diseases of Osaka University ( " BIKEN® " ) > >Suita, Osaka, Japan > >PASTEUR MERIEUX CONNAUGHT > >RHONE-POULENC GROUP > >3814/3819 > >-------------------------------------------------------- >Sheri Nakken, R.N., MA >Vaccination Information & Choice Network, Nevada City CA >530-272-7306 >http://www.nccn.net/~wwithin/vaccine.htm > " All that is necessary for the triumph of evil is that good men ( & >women) do nothing " ...Edmund Burke > >ANY INFO OBTAINED HERE NOT TO BE CONSTRUED AS MEDICAL OR LEGAL ADVICE. THE >DECISION TO VACCINATE IS YOURS AND YOURS ALONE. >Well Within's Earth Mysteries & Sacred Site Tours >http://www.nccn.net/~wwithin >International Tours, Homestudy Courses, ANTHRAX & OTHER Vaccine Dangers >Education, Homeopathic Education >KVMR Broadcaster/Programmer/Investigative Reporter, Nevada City CA >CEU's for nurses, Books & Multi-Pure Water Filters > > >-------------------------------------------------------- >Sheri Nakken, R.N., MA >Vaccination Information & Choice Network, Nevada City CA & Wales UK >$$ Donations to help in the work - accepted by Paypal account >vaccineinfo@... >(go to http://www.paypal.com) or by mail >PO Box 1563 Nevada City CA 95959 530-740-0561 Voicemail in US >http://www.nccn.net/~wwithin/vaccine.htm >ANY INFO OBTAINED HERE NOT TO BE CONSTRUED AS MEDICAL OR LEGAL ADVICE. THE >DECISION TO VACCINATE IS YOURS AND YOURS ALONE. >Well Within's Earth Mysteries & Sacred Site Tours >http://www.nccn.net/~wwithin >International Tours, Homestudy Courses, ANTHRAX & OTHER Vaccine Dangers >Education, Homeopathic Education >CEU's for nurses, Books & Multi-Pure Water Filters > > > > > Quote Link to comment Share on other sites More sharing options...
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